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3-A Sanitary and Hygienic

Darcoid works with Rubber Fab which has a large inventory of O-Rings for Cherry Burrell®, Evergreen®, International Paper®, Pure Pak®, Liqui-Box®, Nimco®, Gram®, Sweetheart®, Portion Pak®, Anderson® and other sanitary fillers. Standard materials available include Buna, EPDM, FKM and Silicone.The gasket materials considered are Tuf-Steel® (PTFE/Stainless Steel),Tuf-Flex®, PTFE, Silicone (Platinum), FKM Fluoroelastomer, EPDM and Buna-N.

Most decisions driving seal type selection are based on chemistry, temperature, exposure limits, USP, FDA qualifications, and curing methods.

In determining correct sanitary gasket materials, the following criteria are used:

  • U.S. Pharmacopeia Class VI Certification
  • Cytotoxicity Criteria 
  • CFR Title 21 Section 177.1550 
  • CFR Title 21 Section 177.2600 
  • Traceability: Lot and Batch Certification: Lot and Batch 
  • ASME-BPE Standards 
  • USDA Standards 
  • 3-A Sanitary Standards 
  • Current Good Manufacturing Practices (CGMP) 
  • Manufacturer data and specifications 
  • Consultation with various pharmaceutical users
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